Key West, FL, March 11, 2016: Today, the US Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) published in the Federal Register a preliminary finding of no significant impact (FONSI) on Oxitec’s OX513A Aedes aegypti mosquito, which is in agreement with the conclusions of Oxitec’s draft Environmental Assessment (EA). The draft EA and preliminary FONSI will be available for public review and comment beginning Monday, March 14, 2016. After a 30-day public comment period, the FDA will review the comments as part of their evaluation of Oxitec’s proposed trial in Key Haven, FL.
The publication of the FONSI and the EA follows an FDA-led evaluation of potential impacts of Oxitec’s proposed trial on public health and the environment. The team that performed the evaluation consisted of the FDA-CVM, the Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA).
“We need to be proactive when it comes to controlling the Aedes aegypti mosquito,” said Florida Keys Mosquito Control District Executive Director Michael Doyle. “Our ultimate goal is to reduce the population of the Aedes aegypti mosquito to a point where it cannot transmit diseases such as dengue, chikungunya and zika. “A small trial like this is designed to see if highly reducing the population is possible with this technology here in the Keys. If so,” Doyle said, “we will then look at larger trial areas. The Aedes aegypti is the toughest mosquito to control and FKMCD is looking at several different technologies. These technologies, however, take several years to develop and currently Oxitec is the furthest along.”
The purpose of Oxitec’s proposed trial is to determine the efficacy of Oxitec’s OX513A mosquitoes as a control method of the Aedes aegypti mosquito.
The link to the EA and the FONSI will be available on the FKMCD website (http://www.keysmosquito.org) on Monday morning.